510(k) K250016

droplet® personal lancets by Htl-Strefa S.A — Product Code QRK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 1, 2025
Date Received: January 3, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class: Class II
Regulation Number: 878.4850
Review Panel: SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by Htl-Strefa S.A

K220643 — DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe (July 8, 2022)
K202340 — Droplet Pen Needle 30G & 33G (October 15, 2020)
K192082 — Droplet Pen Needle 34G (April 21, 2020)
K171982 — DROPLET PEN NEEDLE (March 21, 2018)
K170988 — DropSafe Safety Pen Needle (December 12, 2017)
K143437 — Droplet Pen Needles (June 25, 2015)

Other clearances for product code QRK

K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
K242622 — Sterile Lancets for Single Use (October 28, 2024)
K241810 — MICROLET®NEXT Lancet (August 15, 2024)
K232330 — Lancing System (January 4, 2024)
K230712 — SG Lanset I, SG Lancets, Soft Lancets (December 6, 2023)
K230310 — STAT Medical Device Lancing System (September 8, 2023)
K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro (June 13, 2023)
K222617 — EasyTouch Lancing Device (March 21, 2023)
K223815 — ONE DROP Lancing Device (February 15, 2023)
K223314 — Disposable Blood Lancets (January 25, 2023)